QA Associate I
22 DNA Way South San Francisco, CA 94080
Bayside Solutions is seeking a QA Associate I to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
QA Associate I
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Biological Technologies (BT) is responsible for the development/optimization, validation, transfer, and technical support for biological test methods used for QC clinical and commercial product.
- The group also supports lot release/stability testing of all clinical products and potency testing for process development and product characterization.
- The candidate will focus primarily on providing general support and maintenance of suspension and adherent human cell lines in GMP testing laboratories, review of GMP paperwork with a potential of performing ELISA, cell based and other potency methods. This includes but is not limited to: weekly human cell line passaging and assay flask preparation, preparation of cell culture and assay media, participation in cell bank production using multilayered flask and Sartorius wave bag technologies, participation in characterizing cell lines using flow cytometry (FACSCalibur) and Incucyte instrumentation, review of pertinent cell culture, reagent preparation, cell banking and other GMP documents.
- Expectations include routine “ sweeps” of the lab to ensure compliance with cGMP, GLP and safety regulations; ordering, stocking and maintaining supply levels for cell culturing activities, utilization of Lean tools such as 5S and Environmental, Health, and Safety practices, routine lab maintenance, project and assay support, and document management as needed.
Summary of Qualifications:
- Requirements: B.S. in Biological Sciences. 1-2 years of relevant experience in Quality Control preferred.
- Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skills for a fast paced environment is a must.
- Must also be dependable and able to work with minimal supervision.
- Familiarity with basic laboratory equipment and maintenance of human cell lines is preferred.
- Experience with, aseptic cell culturing, flow cytometry, BSL level 2 safety, and cGMP familiarity/knowledge are a plus.
- Good computer skills are required, and experience working with FloJo Analysis, ConDor, and Trackwise are a plus.